FDA 510(k)
FDA class 1
Substantially Equivalent
🇳🇴 Norway
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
K Number: K132031
·
Decision Mar 21, 2014
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
4
Review Days
246
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Basic Information
- Device Name
- AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
- K Number
- K132031
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axis-Shield Poc AS
- Date Received
- July 18, 2013
- Decision Date
- March 21, 2014
- Product Code
- CHH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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